When an inspector from a regulatory agency comes into your pharmacy without warning, it can be startling. Even if you know you are doing everything right, there’s still that overwhelming feeling that something might come back non-compliant on the inspection report.
As pharmacists ourselves, we know this feeling all too well – so we created a plan to prepare for and handle these inspections.
Chances are you will not have advance notice before inspectors come knocking on your door, so it is best to be prepared at all times. Start by taking some time to put together in writing a policy on what to do when the inspectors come in. Do a walk-through of your facility yourself, acting as if you were an inspector. What things might you want to know about? What areas might you be most interested in? Take questions like these into account and answer them in your written policy.
A very bare-bones example of such a policy might look like this:
It is the policy of ________to conduct its practice at the highest levels of compliance with Drug Enforcement Administration laws (Controlled Substances Act), regulations (CFR Part 1300 to End), policies and emerging best practice procedural recommendations of the DEA as they apply to retail pharmacy registrants.
The purpose of this document is to describe the standard operating procedure to ensure that ___________handles a DEA unannounced, unscheduled inspection and/or investigation in compliance with the registrant’s regulatory and standard operating requirements.
It is the desire of ______to ensure a productive inspection and positive experience for the pharmacy, its patients and for the DEA investigators and agents, and also to meet the expectations of the DEA.
Once this policy statement is created, prepare your staff by providing them with a copy and making sure everyone reads and signs it. You’ll thank yourself later for putting in some time here.
The day has come. The inspectors have arrived and, ideally, you have been preparing yourself and your staff for this situation. Make sure to greet agency inspectors and verify all credentials. Inform the inspectors that the pharmacy intends to ensure a productive inspection and meet the expectations of the agency. Provide a copy of the policy statement to inspectors. Indicate that the pharmacy administration and staff are required to notify specified individuals prior to consenting to the inspection.
Also, pharmacy staff must arrange for adequate staffing while inspectors are present to ensure patient safety. This is simply to make sure your pharmacy can still function while an inspection is in progress.
Escort the inspectors into a separate office, conference room or area that will provide for conversation and discussion. Review (and sign if instructed by pharmacy administration or MOR the DEA Form 82 (Notice of Inspections of Controlled Premises). The MOR or designee must accompany and cooperate with the investigators during inspection and respond to questions.
Take notes on any suggestions or criticisms mentioned during inspection. Any corrections that can be made immediately, should be made and documented while the inspection is in progress.
This part is simple. As long as you have taken notes diligently during the inspection, you should be able to create a checklist of errors that need to be corrected. Prepare a formal report from your notes and the inspectors’ review of their findings. Use this report to help guide you and your staff make any necessary corrections.
Once your corrections have been made, inform the inspection agency – and then prepare for your follow-up inspection.
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